Literature DB >> 26194550

Regulatory science: Trust and transparency in clinical trials of medical devices.

Daniel B Kramer1, Donald E Cutlip1.   

Abstract

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Year:  2015        PMID： 26194550      PMCID： PMC4698975          DOI： 10.1038/nrcardio.2015.112

Source DB:  PubMed          Journal:  Nat Rev Cardiol        ISSN： 1759-5002            Impact factor:   32.419


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  6 in total

1.  Scientific evidence underlying the ACC/AHA clinical practice guidelines.

Authors:  Pierluigi Tricoci; Joseph M Allen; Judith M Kramer; Robert M Califf; Sidney C Smith
Journal:  JAMA       Date:  2009-02-25       Impact factor: 56.272

2.  Regulation of medical devices in the United States and European Union.

Authors:  Daniel B Kramer; Shuai Xu; Aaron S Kesselheim
Journal:  N Engl J Med       Date:  2012-02-14       Impact factor: 91.245

3.  A randomized study of how physicians interpret research funding disclosures.

Authors:  Aaron S Kesselheim; Christopher T Robertson; Jessica A Myers; Susannah L Rose; Victoria Gillet; Kathryn M Ross; Robert J Glynn; Steven Joffe; Jerry Avorn
Journal:  N Engl J Med       Date:  2012-09-20       Impact factor: 91.245

4.  Compliance with results reporting at ClinicalTrials.gov.

Authors:  Monique L Anderson; Karen Chiswell; Eric D Peterson; Asba Tasneem; James Topping; Robert M Califf
Journal:  N Engl J Med       Date:  2015-03-12       Impact factor: 91.245

5.  Premarket clinical evaluation of novel cardiovascular devices: quality analysis of premarket clinical studies submitted to the Food and Drug Administration 2000-2007.

Authors:  Daniel B Kramer; Elias Mallis; Bram D Zuckerman; Barbara A Zimmerman; William H Maisel
Journal:  Am J Ther       Date:  2010 Jan-Feb       Impact factor: 2.688

6.  Selective reporting in trials of high risk cardiovascular devices: cross sectional comparison between premarket approval summaries and published reports.

Authors:  Lee Chang; Sanket S Dhruva; Janet Chu; Lisa A Bero; Rita F Redberg
Journal:  BMJ       Date:  2015-06-10
  6 in total
  1 in total

1.  Factors associated with reporting results for pulmonary clinical trials in ClinicalTrials.gov.

Authors:  Isaretta L Riley; L Ebony Boulware; Jie-Lena Sun; Karen Chiswell; Loretta G Que; Monica Kraft; Jamie L Todd; Scott M Palmer; Monique L Anderson
Journal:  Clin Trials       Date:  2017-11-10       Impact factor: 2.486
  1 in total

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